FDA Registration
Active
🇨🇳 China
FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM
Reg #: 3007421145
·
FEI: 3004173703
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd.
- Registration Number
- 3007421145
- FEI Number
- 3004173703
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3-6/F, Building 1, 3B/F, 4/F, Building 2, and 5-7/F, Building 3, Rundongsheng Industrial Park, Longteng, Xixiang, Baoan District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K070850
Owner / Operator
- Firm Name
- Flextronics International USA, Inc.
- Operator Number
- 9006592
- Address
- 6201 America Center Drive
- City
- San Jose
- State
- CA
- Postal Code
- 95002
- Country
- US
- Correspondent
- Chad Ashton
US Agent
- Business Name
- FLEXTRONICS INTERNATIONAL USA, INC.
- Contact Name
- Chad Ashton
- Address
- 12455 Research Blvd
- City
- Austin
- State
- TX
- ZIP
- 78759
- Country
- US
- [email protected]
- Phone
- 901 8712423
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2008-12-09 |
Proprietary Names
FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM
FREESTYLE LITE BLOOD GLUCOSE MONITO
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)